All > Seborrheic Dermatitis > Atopic Dermatitis

etrasimod for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
California Allergy and Asthma Medical Group, Los Angeles, CAAtopic Dermatitis+2 Moreetrasimod - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and effectiveness of etrasimod, a pill taken once daily, to treat moderate-to-severe atopic dermatitis (eczema) in adults who tried treatments that work all over the body and saw no effects. Participants will visit the clinic 6-12 times over 16-68 weeks, with tests for signs/symptoms, blood samples and vital signs.

Eligible Conditions
  • Atopic Dermatitis
  • Eczema

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
1
Tavapadon Followed by Tavapadon + Carbamazepine
1
Amlitelimab

Study Objectives

40 Primary · 2 Secondary · Reporting Duration: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2

Week 68
Part 1 OLE and Part 2: Change from Baseline in AP, ALT (SGPT), AST (SGOT) (U/L)
Part 1 OLE and Part 2: Change from Baseline in ECG values (PR interval)
Part 1 OLE and Part 2: Change from Baseline in ECG values (QRS complex)
Part 1 OLE and Part 2: Change from Baseline in ECG values (QT interval)
Part 1 OLE and Part 2: Change from Baseline in ECG values (QTc interval)
Part 1 OLE and Part 2: Change from Baseline in ECG values (heart rate)
Part 1 OLE and Part 2: Change from Baseline in Hematocrit, WBC with diff, TBNK with diff (%)
Part 1 OLE and Part 2: Change from Baseline in Hemoglobin (g/dL)
Part 1 OLE and Part 2: Change from Baseline in Platelets, WBC, and WBC with diff (x10^3/uL)
Part 1 OLE and Part 2: Change from Baseline in RBC (x10^6/uL)
Part 1 OLE and Part 2: Change from Baseline in Serum Sodium, Serum Potassium (mmol/L)
Part 1 OLE and Part 2: Change from Baseline in TBNK Panel (abs/uL)
Part 1 OLE and Part 2: Change from Baseline in Total Protein and Albumin-BCG (g/dL)
Part 1 OLE and Part 2: Change from Baseline in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL)
Part 1 OLE and Part 2: Change from Baseline in urinalysis (pos/neg local dipstick)
Part 1 OLE and Part 2: Change from Baseline in vital sign values (BP)
Part 1 OLE and Part 2: Change from Baseline in vital sign values (pulse rate)
Part 1 OLE and Part 2: Change from Baseline in vital sign values (respiratory rate)
Part 1 OLE and Part 2: Change from Baseline in vital sign values (temperature)
Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest.
Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L)
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (PR interval)
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QRS complex)
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QT interval)
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QTc interval)
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (heart rate)
Part 1 OLE and Part 2: Incidence of clinically significant changes in Hematocrit, WBC with Diff, TBNK with Diff (%)
Part 1 OLE and Part 2: Incidence of clinically significant changes in Hemoglobin (g/dL)
Part 1 OLE and Part 2: Incidence of clinically significant changes in Platelets, WBC, and WBC with Diff (x10^3/uL)
Part 1 OLE and Part 2: Incidence of clinically significant changes in RBC (x10^6/uL)
Part 1 OLE and Part 2: Incidence of clinically significant changes in Serum Sodium, Serum Potassium (mmol/L)
Part 1 OLE and Part 2: Incidence of clinically significant changes in TBNK panel (abs/uL)
Part 1 OLE and Part 2: Incidence of clinically significant changes in Total Protein and Albumin-BCG (g/dL)
Part 1 OLE and Part 2: Incidence of clinically significant changes in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL)
Part 1 OLE and Part 2: Incidence of clinically significant changes in urinalysis (pos/neg local dipstick)
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (BP)
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (pulse rate)
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (respiratory rate)
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (temperature)
at Week 16
Part 1 DB: Percent change from baseline in EASI
Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline
Part 1 DB: Proportion of participants achieving a EASI-75

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg
1
Tavapadon Followed by Tavapadon + Carbamazepine
2
Amlitelimab

Trial Design

2 Treatment Groups

etrasimod
1 of 2
Placebo (Part 1 DB period only)
1 of 2

Experimental Treatment

Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: etrasimod · Has Placebo Group · Phase 2 & 3

etrasimod
Drug
Experimental Group · 1 Intervention: etrasimod · Intervention Types: Drug
Placebo (Part 1 DB period only)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 68 weeks in part 1 and up to 52 weeks in part 2

Who is running the clinical trial?

PfizerLead Sponsor
4,352 Previous Clinical Trials
7,171,638 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,307 Previous Clinical Trials
4,836,064 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Does this research require participants to be of legal age?

"The qualifications for this medical trial necessitate that participants lie between 18 and 80 years old. There are 105 trials dedicated to minors under the age of 18, and 170 specifically catering towards seniors over 65 years in age." - Anonymous Online Contributor

Unverified Answer

Does my background qualify me to partake in this experiment?

"The requirements to be admitted into this medical trial include having a diagnosis of atopic dermatitis and being between 18-80 years old. There is capacity for approximately 400 individuals to participate." - Anonymous Online Contributor

Unverified Answer

How many venues are currently hosting this clinical trial?

"Akumin Imaging in Tampa, Michigan, Clinical Research Trials of Florida in Lathrup Village, South Dakota, and Tampa Eye Clinic in Troy, Texas are among the 10 clinical sites administering this trial." - Anonymous Online Contributor

Unverified Answer

What is the present size of this research project's participant population?

"This study necessitates the inclusion of 400 eligible patients. Participants can enroll at Akumin Imaging in Tampa, Michigan and Clinical Research Trials of Florida in Lathrup Village, South Dakota." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for patient enrolment in this investigation?

"Clinicaltrials.gov confirms that recruitment for this clinical trial is ongoing, beginning on January 18th 2023 and most recently updated February 7th 2023." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top